FDA.reportPublic FDA data

Application 090227

Type
ANDA
Sponsor
SANDOZ

Application Products#

Product, Drug, Ingredient table
ProductDrugIngredientFormStrengthReference drugReference standard
001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUMTABLET, EXTENDED RELEASE;ORAL1GM;EQ 62.5MG BASENoNo

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUMAMOXICILLIN; CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRS2010-04-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A090227-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 2 of 2 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2022-10-28 04:53 UTC2022-10A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALRS2010-04-21cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090227-001AMOXICILLIN AND CLAVULANATE POTASSIUM1GM;EQ 62.5MG BASETABLET, EXTENDED RELEASE / ORALABRS2010-04-21a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-10-15 13:18:302026-09A090227-001AB1c2088c7a36db…
2026-09-14 22:38:342026-08A090227-001AB184e616aacf4f…
2026-08-18 06:07:402026-07A090227-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090227-001AB1011fe1cb6892…
2019-12-13 00:20 UTC2019-12A090227-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090227-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090227-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090227-001AB1ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A090227-001AB1a50c72e98297…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSportpharm LLCcd7d2c0c-bf58-457a-b3d1-bb4c167cd1272026-04-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090227
application number: ANDA090227
Amoxicillin and Clavulanate PotassiumAMOXICILLIN AND CLAVULANATE POTASSIUMSandoz Ince41387c8-2c74-4990-831f-64dc921ee1382025-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090227
application number: ANDA090227
ndc (product): 0781-1943

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 4 matching rows.

NDC, Name, Nonproprietary name table
NDCNameNonproprietary nameLabelerMarketing categoryStatus
0781-1943Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1943Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1943Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent
0781-1943Amoxicillin and Clavulanate PotassiumAmoxicillin and Clavulanate PotassiumSandoz IncANDACurrent

Documents#

Document, Submission type, Date table
DocumentSubmission typeDate
9263ORIG2010-04-23